Legal & Regulatory

A US-China Economic and Security Review Commission report highlights China’s tightening grip on APIs, biomanufacturing, and R&D services, raising alarms about supply chain vulnerabilities, data transparency gaps, and the urgent need for US policy action.

This episode of Pharma Pulse discusses FDA’s growing National Priority Voucher initiative, fresh data on oral semaglutide’s cardiometabolic impact, and Mark Cuban’s latest drug addition that signals key shifts in innovation, access, and affordability across the pharmaceutical landscape.

Nine drugs from leading manufacturers will participate in HRSA’s new 340B rebate model pilot program, set to begin in 2026, which aims to evaluate a rebate-based framework for future drug pricing models amid ongoing industry litigation.

This episode of Pharma Pulse discusses Novartis’ $12 billion acquisition of Avidity Biosciences to expand its RNA therapeutics portfolio, and President Trump’s proposed 10% tariff increase on Canadian imports that could disrupt pharma supply chains.

The move adds new tension to US-Canada trade relations under the USMCA and raises questions about pending pharmaceutical import policies.

This episode of Pharma Pulse discusses new data showing a post-Dobbs surge in telehealth medication abortion requests, the FDA’s expedited review of Tzield under its new National Priority Voucher Program, and the launch of a dedicated biopharma air logistics network by Frontier Scientific Solutions and ATSG.

This episode of Pharma Pulse covers Amazon and WeightWatchers’ partnership to deliver FDA-approved weight-loss medications, Merck’s new biomanufacturing center of excellence in Virginia, and the FDA’s first-ever approval of a TSLP-targeting biologic, Tezspire, for chronic rhinosinusitis with nasal polyps.

The company’s new 400,000-square-foot facility in Elkton will boost small molecule manufacturing, create hundreds of jobs, and strengthen US innovation and supply chain resilience.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how FDA officials are signaling a balanced enforcement approach when it comes to DSCSA enforcement, expecting compliance efforts and documentation, but also recognizing that perfection will take time.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, details that after a year of steady progress, manufacturers and distributors report over 97% data accuracy under DSCSA traceability requirements, marking a major milestone in supply chain interoperability and signaling confidence ahead of the November compliance deadline.

The $445 million expansion of AstraZeneca’s Coppelsite will boost global production capacity for Lokelma, enhance local job growth, and strengthen the company’s US manufacturing footprint amid industry-wide onshoring trends.

Kala Shankle, JD, HDA’s vice president of regulatory affairs, describes how at this year’s seminar, attendees emphasized pragmatic approaches to achieving full compliance while anticipating upcoming FDA rules that could reshape wholesale and 3PL licensure standards across the pharma supply chain.

This episode of Pharma Pulse covers the FDA’s approval of a rapid one-minute HIV self-test, the US government’s decision to delay tariffs on pharmaceutical exports from Singapore, and CVS Pharmacy’s acquisition of more than 600 Rite Aid stores across three states to expand its community health footprint.

A planned 100% tariff on branded and patented drugs from Singapore is being postponed as US and Singapore officials explore potential exemptions.

In the third part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, explains how healthcare organizations can harmonize both approaches by prioritizing fairness, transparency, and adaptable systems.

In the second part of her Pharma Commerce video interview, Linda Malek, JD, partner at Crowell & Moring, notes that by bringing regulators and innovators together, regulatory sandboxes could help US healthcare organizations test and refine AI tools responsibly, which allows oversight agencies to keep pace with rapid technological change.

The fallout is impacting partners Scholar Rock and Regeneron, both of whom have pending regulatory applications tied to the facility.

The global generics maker’s new Florida site will produce more than 25 critical respiratory medicines, create over 200 jobs, and reinforce domestic manufacturing and drug security.

The new Albemarle County site—reportedly the largest investment in AstraZeneca’s history—will focus on API and ADC production, create 3,600 jobs, while strengthening US pharma supply chain resilience.

This episode of Pharma Pulse covers the CDC’s new individualized approach to COVID-19 vaccination and changes to chickenpox guidance for toddlers, new research showing how GLP-1 therapies can interfere with PET-CT imaging results, and the Third Circuit Court’s rejection of Novo Nordisk’s IRA challenge.

The appellate court upheld Medicare’s authority to negotiate lower drug prices under the Inflation Reduction Act, following similar rulings against AstraZeneca, Bristol Myers Squibb, and Novartis.

As AI adoption accelerates across life sciences, Shawn Opatka, VP and GM of Honeywell Life Sciences, and Linda Malek, JD, partner at Crowell & Moring, discuss how regulatory expectations and federal initiatives—like the White House AI Action Plan—are shaping the technology’s future role in pharma quality, traceability, and healthcare systems.

The investment will establish a new hub overseeing contract manufacturing across India and expand Lilly’s global supply of medicines for Alzheimer’s, diabetes, obesity, and cancer, amid shifting US trade and tariff policies.

Advice for pharma distributors and dispensers on what they should do now in order to solidify a secure supply chain.

This episode of Pharma Pulse covers the FDA’s quiet approval of the first generic mifepristone tablet, Takeda’s decision to discontinue cell therapy research programs, and SciSafe’s expansion of biopharma storage capacity with a new East Brunswick, New Jersey facility.